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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 26.06.2023
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Endoreg is an orally-active semisynthetic, steroidal progestogen (or progestin). It is available for use as an oral contraceptive in combination with ethinylestradiol. It has antiandrogenic activity and as a result can improve androgenic symptoms. It is a non-ethinylated progestin which is structurally related to testosterone. Endoreg given in isolation is available for the treatment of endometriosis under the trade name Endoreg.
WHAT AILYN IS AND WHAT IT IS USED FOR
Ailyn is a combined oral contraceptive tablet (COC) that contains two types of hormones, an estrogen (ethinyl estradiol) and a progestogen (dienogest).
Ailyn is used to prevent pregnancy.
HOW TO TAKE AILYN
Follow exactly the instructions for taking this medicine as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
When and how are tablets taken?
- One container of Ailyn contains 21 coated tablets.
Each tablet is marked on the day of the week on which it is to be taken. Take the tablet every day at about the same time, with a little water. Follow the direction of the arrows until you have taken the 21 coated tablets. During the 7 following days you should not take any tablets. You should start a rule during these 7
Starting the first Ailyn package
When a hormonal contraceptive has not been used in the previous month
Start taking Ailyn on the first day of the cycle, that is, the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if the period begins on a Friday, take a tablet marked Friday. Continue then the days in order.
When you have used another combination contraceptive tablet, a vaginal ring or a transdermal patch before
You can start taking Ailyn the day after taking the last tablet from the current tablet pack (which means there will be no tablet-free period) or after removal of the vaginal ring or transdermal patch. If the current tablet pack also contains inactive tablets, you can start taking Ailyn the day after you take the last active tablet (if you are not sure what this tablet is, consult your doctor or pharmacist).
You can also start taking Ailyn on the last day after the usual interval without a tablet, without a patch, without a ring or with a placebo tablet from previous treatment.
When you have used a progestin-only tablet before
You can stop taking the tablet any day and start taking Ailyn the next day at the same time.
When you have used a progestogen-releasing injectable, implant, or intrauterine system (SIU) before
Start taking Ailyn when you have the next injection or on the day the implant or IUS is removed. But you should always use another method of birth control (a barrier method) for the first 7 days when you take new tablets when you have sex.
After childbirth
Do not start taking Ailyn for at least 21 to 28 days after childbirth. During the first 7 on days when you take the tablets, you must also use a barrier method of contraception (e.g., a condom). If you have already had sex, a pregnancy should be ruled out before you start taking Ailyn, or you should wait for your first period to occur. For use during lactation, see " pregnancy and lactation"”
After a spontaneous or induced abortion
Your doctor may advise you in this regard.
What to do if you have stomach problems (e.g. vomiting, severe diarrhea)
If you vomit in the 3 to 4 hours after taking the Ailyn tablet, the active components may not have been fully absorbed. This is as if I forgot to take a tablet. Therefore, follow the instructions for the missed tablets. If you suffer from severe diarrhea, consult your doctor.
What to do if you want to delay the rule
You can delay the rule if you start the next pack of Ailyn immediately after finishing the current pack. You can continue with this container for as long as you want, until you have finished it. When you want to have your period, it will be enough to stop taking the tablets. While taking the second container, irregular bleeding may appear. Start the next pack after the usual 7-hour break everyday.
What to do if you want to change the start day of the rule
If you take the tablets in the indicated way, you will have the rule about the same day every 4 few weeks. If you want to change the day, it will be enough to shorten (never prolong) the interval between the packages. If, for example, your rule usually starts on Friday and you want it to start on Tuesday (3 days before), you should start the next Pack 3 days earlier than usual. If you pause without tablets very short (e.g. 3 days or less), you may not have the rule during the break. You may have some irregular bleeding during use of the following container.
What to do if you experience unexpected bleeding
With all contraceptive tablets bleeding (irregular bleeding) may appear between the rules during the first months. You may need to use compresses or tampons, but you should continue to take the tablets as normal. Irregular bleeding usually stops when the body has adapted to the contraceptive tablet (usually after 3 days). cycles of taking the tablet). If it continues, intensifies or starts again, tell your doctor.
What to do if you do not have a rule
If you have taken all the tablets at the right time and have not had vomiting or taken other medicines, you are unlikely to be pregnant. Keep taking Ailyn as usual. If you have not had your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of Ailyn until your doctor has verified that you are not pregnant.
If you take more Ailyn than you should
No serious adverse effects have been reported as a result of taking too many Ailyn tablets at once. If you have taken several tablets at once, you may experience nausea, vomiting and vaginal bleeding. If you find that a child has taken Ailyn, ask your doctor for advice.
In case of overdose or accidental ingestion consult your doctor or pharmacist or call the toxicological Information Service, Phone 91 562 04 20, indicating the medication and the amount ingested
If you forgot to take Ailyn
- If the delay in taking one tablet is less than 12 the reliability of the tablet is the same. Take the tablet as soon as you remember, and take the next tablets at the usual time.
- If the delay in taking any tablet is more than 12 the reliability of the tablet may be reduced. The more consecutive tablets you have forgotten, the greater the risk of decreased contraceptive effectiveness. There is an especially high risk of becoming pregnant if you forget to take the tablets at the beginning or end of the package. Therefore, you should follow the rules given below (See also the diagram below).
Forgetting more than 1 compressed in a container
Consult your doctor.
Forgetting 1 tablet at Week 1
Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time. Take additional contraceptive precautions (barrier method) in the 7 following days. If you have had sex in the week before forgetting the tablet, there is a chance that you will become pregnant. Therefore, you should inform your doctor immediately.
Forgetting 1 tablet at Week 2
Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time. The reliability of the tablet is maintained. You do not need to take additional contraceptive precautions.
Forgetting 1 tablet at Week 3
You can choose one of the following options, without taking extra precautions:
1. Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time. Start the next pack as soon as the current pack is finished, so that there is no pause between the packs. You may not have your period until the second pack is finished, and you may have irregular bleeding on the days you take tablets.
Or:
2. Stop taking the tablets from the current pack, pause without 7 tablets days or less (also counts the day you forgot the tablet) and proceed to the next pack. If you follow this method, you can always start the next pack on the same day of the week that you usually do.
- If you have forgotten to take tablets from a container and do not have the rule in the next break without tablets, you may be pregnant. Consult your doctor before starting the next pack.
More than 1 compressed ? Consult your doctor
forget
?
Yes
?
? Week 1 ? Did you have sex in the week before you forgot?
?
No
?
* Take the forgotten tablet
* Take contraceptive precautions for 7 days everyday
* Complete container
Only 1 forgotten tablet
(delay of more than 12 Desk) ? Week 2 ? * Take the tablet forget
* Complete container
* Take the forgotten tablet
? * Complete container
* Proceed to the next container
? Week 3 or
* Stop taking the current container
? * Pause without tablets • no more than 7 days, including days when you forgot to take the tablets)
* Proceed to the next container
If you stop taking Ailyn
You can stop taking Ailyn at any time. If you do not want to get pregnant, ask your doctor about other methods of birth control. If you stop taking Ailyn because you want to get pregnant, it is usually recommended to wait until you have a natural period before trying to get pregnant. This will make it easier to determine that the absence of bleeding is due to being pregnant.
Use in children and adolescents
Ailyn should not be given before the first menstruation (menarche).
Elderly people
Ailyn should not be given after menopause.
Patients with hepatic impairment
Ailyn should not be used in women with severe liver disease (see section “when you should not use Ailyn”).
Patients with renal impairment
The administration of Ailyn in women with renal impairment has not been studied.
Ailyn should not be used in women with severe renal impairment or acute renal failure (See section “when you should not use Ailyn”).
If you have any other questions about the use of this product, ask your doctor or pharmacist.
Hypersensitivity to Endoreg or to any of the excipients of Endoreg.
Endoreg should not be used in the presence of any of the conditions listed as follows, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during the use of Endoreg, treatment must be discontinued immediately: Active venous thromboembolic disorder, arterial and cardiovascular disease, present or in history (eg, myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal, liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies; undiagnosed vaginal bleeding.
Use in pregnancy: There are limited data from the use of Endoreg in pregnant women. Animal studies and data from women exposed to Endoreg during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Endoreg should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Effects of Other Medicaments on Endoreg: Individual Enzyme Inducers or Inhibitors (CYP3A4): Progestogens including Endoreg are metabolized mainly by the cytochrome P450 (CYP450) 3A4 system (CYP3A4) located both in the intestinal mucosa and in the liver. Therefore, inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism.
An increased clearance of sex hormones due to enzyme induction may reduce the therapeutic effect of Endoreg and may result in adverse effects eg, changes in the uterine bleeding profile.
A reduced clearance of sex hormones due to enzyme inhibition may increase the exposure to Endoreg and may result in adverse effects.
Substances with Enzyme-Inducing Properties: Interactions can occur with drugs (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, nevirapine and products containing St. John's wort) that induce microsomal enzymes (eg, CYP450 enzymes) which can result in increased clearance of sex hormones.
Maximum enzyme induction is generally not seen for 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of therapy.
The effect of the CYP3A4 inducer rifampicin was studied in healthy postmenopausal women. Co-administration of rifampicin with estradiol valerate/Endoreg tablets led to significant decreases in steady state concentrations and systemic exposures of Endoreg. The systemic exposure of Endoreg at steady state, measured by AUC0-24 hrs, was decreased by 83%.
Substances with Enzyme-Inhibiting Properties: Known CYP3A4 inhibitors eg, azole antifungals (eg, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (eg, erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (eg, ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (eg, nefazodone, fluvoxamine, fluoxetine) and grapefruit juice may increase plasma levels of progestogens and result in adverse effects.
In a study investigating the effect of CYP3A4 inhibitors (ketoconazole, erythromycin) on the combination of estradiol valerate/Endoreg, steady state Endoreg plasma levels were increased. Co-administration with the strong inhibitor ketoconazole resulted in a 186% increase of AUC0-24 hrs at steady state for Endoreg. When co-administered with the moderate inhibitor erythromycin, the AUC0-24 hrs of Endoreg at steady state was increased by 62%. The clinical relevance of these interactions is unknown.
Effects of Endoreg on Other Medicaments: Based on in vitro inhibition studies, a clinically relevant interaction of Endoreg with the CYP450 enzyme-mediated metabolism of other medicaments is unlikely.
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Drug-Food Interactions: A standardized high fat meal did not affect the bioavailability of Endoreg.
Other Forms of Interactions: The use of progestogens may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins eg, lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.
Summary of the Safety Profile: Adverse effects are more common during the first months after start of intake of Endoreg and subside with duration of treatment. The following adverse effects have been reported in users of Endoreg.
The most frequently reported adverse effects during treatment that were considered at least possibly related to Endoreg were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Endoreg are summarized in the table as follows. Within each frequency grouping, adverse effects are presented in order of decreasing frequency. Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1000 to <1/100).
*The frequencies are based on pooled data of 4 clinical trials including 332 patients (100%).
*The most appropriate MedDRA term (version 11.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
Description of Selected Adverse Reactions: Uterine Bleeding Irregularities: Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the WHO 90 days reference period method. During the first reference period (ie, first 90 days of treatment with Endoreg): The following bleeding patterns were observed (n=290; 100%): Amenorrhea (1.7%), infrequent bleeding (27.2%), frequent bleeding (13.4%), irregular bleeding (35.2%), prolonged bleeding (38.3%), normal bleeding ie, none of the previous categories (19.7%).
During the 4th reference period, the following bleeding patterns were observed (n=149; 100%): Amenorrhea (28.2%), infrequent bleeding (24.2%), frequent bleeding (27.2%), irregular bleeding (21.5%), prolonged bleeding (4%), normal bleeding ie, none of the previous categories (22.8%), changes in menstrual bleeding were only occasionally reported as adverse event by the patients.